A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC36 Tablets for Oral Use in Adult Participants With Obesity or Overweight

NCT07893106 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ASC36o-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, placebo-controlled, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of ASC36 Tablets for Oral Use in Adult Participants with Obesity or Overweight

Conditions

Chronic Weight Management

Keywords

Chronic Weight Management; Obesity; Amylin receptor

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  A summary of AEs, SAEs, and other non-serious adverse events following single oral dose of ASC36 tablets

  From baseline to the end of treatment (up to 10 weeks or Day 70)

Secondary Outcomes (10)

• Cmax of ASC36 Tablets

  From baseline to the end of treatment (up to 10 weeks or Day 70)

• Tmax of ASC36 Tablets

  From baseline to the end of treatment (up to 10 weeks or Day 70)

• AUC of ASC36 Tablets

  From baseline to the end of treatment (up to 10 weeks or Day 70)

• Half-life of ASC36 Tablets

  From baseline to the end of treatment (up to 10 weeks or Day 70)

• Percent Change From Baseline in Body Weight

  From baseline to the end of treatment (up to 10 weeks or Day 70)

Study Arms (8)

Part 1 (SAD) Cohort 1

EXPERIMENTAL

SAD Dose 1

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Part 1 (SAD) Cohort 2

EXPERIMENTAL

SAD Dose 2

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Part 1 (SAD) Cohort 3

EXPERIMENTAL

SAD Dose 3

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Part 1 (SAD) Cohort 4

EXPERIMENTAL

SAD Dose 4

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Part 1 (SAD) Cohort 5

EXPERIMENTAL

SAD Dose 5

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Part 2 (MAD) Cohort 1

EXPERIMENTAL

MAD Dose 1

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Part 2 (MAD) Cohort 2

EXPERIMENTAL

MAD Dose 2

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Part 2 (MAD) Cohort 3

EXPERIMENTAL

MAD Dose 3

Drug: ASC36 tablets, for oral use; Drug: ASC36 placebo tablets

Interventions

ASC36 tablets, for oral use DRUG

ASC36 tablets are an investigational formulation of ASC36 administered orally

Part 1 (SAD) Cohort 1; Part 1 (SAD) Cohort 2; Part 1 (SAD) Cohort 3; Part 1 (SAD) Cohort 4; Part 1 (SAD) Cohort 5; Part 2 (MAD) Cohort 1; Part 2 (MAD) Cohort 2; Part 2 (MAD) Cohort 3

ASC36 placebo tablets DRUG

ASC36 placebo tablets are a plaecbo formulation matching ASC36 tablets, administered orally

Part 1 (SAD) Cohort 1; Part 1 (SAD) Cohort 2; Part 1 (SAD) Cohort 3; Part 1 (SAD) Cohort 4; Part 1 (SAD) Cohort 5; Part 2 (MAD) Cohort 1; Part 2 (MAD) Cohort 2; Part 2 (MAD) Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have provided informed consent before initiation of any study-specific procedures.
• Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive) at screening.
• Otherwise healthy participants with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 to \<30 kg/m2).
• Female participant is eligible to participate if she is not pregnant, breastfeeding, or planning to breastfeed, and one of the following conditions applies:
• Is a woman of nonchildbearing potential (postmenopausal \[12 months of amenorrhea with follicle-stimulating hormone level consistent with a postmenopausal state \[FSH≥30 mIU/mL)\]; or surgically sterile \[hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation\]).
• Is a WOCBP and agrees to use a highly effective contraceptive method (heterosexual abstinence as a lifestyle, or a male condom in conjunction with a second method of contraception that is one of the following: established combined estrogen and/or progesterone hormonal contraception (e.g. oral contraceptive pill), depot injection, contraceptive implant, or intra-uterine device) and refrain from donating egg starting from one month before the first dose and lasting until 6 months or 5 half lives, whichever is longer, after the last dose.

You may not qualify if:

• Have evidence of any clinically significant active or chronic disease (with the exception of obesity or overweight).
• Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
• Have used prescription drugs that promote weight loss within 6 months prior to the first dose of investigational product.
• Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.
• Presence/history of cardiovascular disease incl. stable/unstable angina, MI, TIA, stroke, cardiac decompensation, clinically significant arrhythmias or conduction disorders.
• Have a lifetime history of suicide attempt.
• Participants who have any history of hypersensitivity or intolerance to amylin receptor agonists, related compounds, or drugs of similar mechanisms of action (MoA).
• Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or abnormal liver enzymes as defined as follows at screening.
• Total bilirubin \> 1.5x upper limit of normal (ULN);
• AST \> 1.5x ULN;
• ALT \> 1.5x ULN.
• Have an electrocardiogram (ECG) abnormality at screening as defined as follows:
• QTcF interval \> 450 ms (male) or 470 ms (female)
• PR (PQ) interval prolongation (\> 200 ms)
• Intermittent second or third-degree AV block, or AV dissociation

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

Study Sites (1)

Ascletis Clinical Site

South Miami, Florida, 33143, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ascletis Recruiting

CONTACT

+1 2068073688; clinicaltrials@ascletis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: October 13, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)